Fiber-reinforced fixation implant for proximal interphalangeal joint arthrodesis shows advanced implant bio-integration at 2-year follow-up.

MedStar author(s):
Citation: Journal of Foot & Ankle Surgery. 2022 Jun 23PMID: 35773179Institution: MedStar Union Memorial HospitalDepartment: Orthopaedic SurgeryForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2022Local holdings: Available online through MWHC library: 2003 - present, Available in print through MWHC library:1999-2007ISSN:
  • 1268-7731
Name of journal: Foot and ankle surgery : official journal of the European Society of Foot and Ankle SurgeonsAbstract: BACKGROUND: A bio-integrative fiber-reinforced implant (OSSIOfiber R Hammertoe Fixation Implant, OSSIO Ltd., Caesarea, Israel) for proximal interphalangeal joint (PIPJ) correction-arthrodesis showed partial bio-integration at 1-year follow-up (1FU) in a previous study. The study was prolonged to assess the bio-integration at 2-year-follow-up (2FU).CONCLUSIONS: This study demonstrates 96 % PIPJ fusion rate and increased bio-integration from 1FU to 2FU, reaching advanced bio-integration of the fiber-reinforced implant at 2FU. Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.METHODS: Twenty-four patients with proximal interphalangeal joint (PIPJ) correction-arthrodesis using the fiber-reinforced implant and analysed at 1FU, completed 2FU. Follow-up included clinical examination, patient reported outcomes, radiographs, MRI and bio-integration scoring. Results were compared between the 1FU and 2FU (paired t-test).RESULTS: Radiographs confirmed fusion in 96 % (n = 23) at 2FU (1FU, 92 % (n = 22)). Implant was no longer visible in 21 % (n = 5), partially visible in 33 % (n = 8), and fully visible in 46 % (n = 11)(1FU, fully visible 100 % (n = 24)). The border between implant and surrounding bone was scored not visible in 88 % (n = 21) and partially visible in 12 % (n = 3) (1FU, border partially visible 100 % (n = 24)). There were no cyst formation or fluid accumulation findings 1FU/2FU. Mild bone edema was detected in 4 % (n = 1) (1FU, 29 % (n = 7)). None of the edema findings were considered as adverse implant related. The mean bio-integration score was 9.71 +/- 0.69 at 2FU (1FU, 7.71 +/- 0.46). The parameters of border between implant and bone and bone edema further improved at the 2FU compared to the 1FU, total bio-integration score was also higher at 2FU than 1FU (each p < 0.05).All authors: Cicchinelli LD, Miller S, Richter M, Sofka CM, Stalc JFiscal year: FY2022Digital Object Identifier: Date added to catalog: 2022-09-26
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Journal Article MedStar Authors Catalog Article 35773179 Available 35773179

Available online through MWHC library: 2003 - present, Available in print through MWHC library:1999-2007

BACKGROUND: A bio-integrative fiber-reinforced implant (OSSIOfiber R Hammertoe Fixation Implant, OSSIO Ltd., Caesarea, Israel) for proximal interphalangeal joint (PIPJ) correction-arthrodesis showed partial bio-integration at 1-year follow-up (1FU) in a previous study. The study was prolonged to assess the bio-integration at 2-year-follow-up (2FU).

CONCLUSIONS: This study demonstrates 96 % PIPJ fusion rate and increased bio-integration from 1FU to 2FU, reaching advanced bio-integration of the fiber-reinforced implant at 2FU. Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.

METHODS: Twenty-four patients with proximal interphalangeal joint (PIPJ) correction-arthrodesis using the fiber-reinforced implant and analysed at 1FU, completed 2FU. Follow-up included clinical examination, patient reported outcomes, radiographs, MRI and bio-integration scoring. Results were compared between the 1FU and 2FU (paired t-test).

RESULTS: Radiographs confirmed fusion in 96 % (n = 23) at 2FU (1FU, 92 % (n = 22)). Implant was no longer visible in 21 % (n = 5), partially visible in 33 % (n = 8), and fully visible in 46 % (n = 11)(1FU, fully visible 100 % (n = 24)). The border between implant and surrounding bone was scored not visible in 88 % (n = 21) and partially visible in 12 % (n = 3) (1FU, border partially visible 100 % (n = 24)). There were no cyst formation or fluid accumulation findings 1FU/2FU. Mild bone edema was detected in 4 % (n = 1) (1FU, 29 % (n = 7)). None of the edema findings were considered as adverse implant related. The mean bio-integration score was 9.71 +/- 0.69 at 2FU (1FU, 7.71 +/- 0.46). The parameters of border between implant and bone and bone edema further improved at the 2FU compared to the 1FU, total bio-integration score was also higher at 2FU than 1FU (each p < 0.05).

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